Recruiting
Phase 1

Gamma Glutamylcysteine

Sponsor:

Pravat Mandal

Code:

NCT07583251

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Gamma- Glutamylcysteine

Gamma- Glutamylcysteine

Gamma- Glutamylcusteine

Study Details

Brief summary:

The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.

Conditions

Mild Cognitive Impairment (MCI)

Study ID

NCT07583251

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Memory complaints;
2. MCI diagnosis
3. MoCA score between 18-25
4. Age 55 - 80 years old.
5. Ability to read and write in English

Exclusion Criteria:

1. Subjects with a history of cancer;
2. Subjects with a history of schizophrenia, manic-depressive disorder
3. Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)
4. Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;

Study Design

Enrollment

9 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gamma - Glutamylcystiene 400

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.

experimental: Gamma - Glutamylcystiene 800

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months

experimental: Gamma - Glutamylcystiene 1200

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months

Interventions

Gamma- Glutamylcysteine

400mg capsules once a day

Gamma- Glutamylcysteine

400mg capsules orally (two times) per day

Gamma- Glutamylcusteine

400mg capsules orally (three times) per day

Primary outcome measure

  • No. of participants with abnormal kidney and liver function tests after 30 days of supplementation. [ Time Frame: 1 month ]
  • Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE. [ Time Frame: 3 months ]
  • Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE. [ Time Frame: 3 months ]
  • Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE. [ Time Frame: 3 months ]
  • Number of participants with abnormal laboratory test results after 3 months of GGC supplementation. [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Pravat Pravat K MANDAL

4126999561mandalpk@pitt.edu

Nazia Pillar

878-670-3123clinic55@pitt.edu

Locations

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Pravat Mandal

4126999561mandalpk@pitt.edu

Nazia Pillar

clinic55@pitt.edu

More Information

Sponsor

Pravat Mandal

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • GSH
  • GGC
  • MCI
  • cognitive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pravat Mandal on 2026-08-07.